Device Category Dossier

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Device Category Dossier for Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay. Australian ARTG records, sponsors, device class —…

Hepatitis

B surface antigen immunoassay devices are chemiluminescent microparticle immunoassays used for qualitative detection of hepatitis B surface antigen in human serum and plasma , with confirmatory assays employing specific antibody neutralisation . These assays aid in diagnosis of hepatitis B virus infection in symptomatic and asymptomatic individuals and serve as screening tests for blood, hemocomponent, organ and tissue donors .